Typically, when a physician prescribes a prescription for a particular medical therapy, the physician may specify a particular brand name for the medical therapy, because the physician is familiar with this brand or, in some instances, the physician may not be aware that there is a substitute medical therapy available. These substitute medical therapies represent additional options for patients, which may provide enhanced benefits, and/or lower cost, depending on the patient's medical care coverage.
For example, a physician could specify a brand name for a therapeutic dosage of an active pharmaceutical ingredient (API), i.e., a “branded product”, when there is a substitute generic pharmaceutical product, approved by a regulatory authority, such as the Food and Drug Administration (FDA), with the same API. In some instances, the generic pharmaceutical may be a direct substitute, i.e., therapeutically and pharmaceutically equivalent or “bioequivalent.” In other instances, the product may contain the same API, at a similar dosage or with a different release profile or dosage form. In yet other instances, there may be substitute pharmaceutical products that treat the same medical condition for which the original branded product was prescribed.
Furthermore, the substitute medical therapy could be an alternative biological or medical device, or another medical therapy. For example, a physician could specify a particular brand of therapeutic proteins, when another brand would provide the patient with greater safety, effectiveness, or a substantial savings, based on the applicable medical insurance coverage for the prescribed medical therapy. Likewise, there could be a substitute medical device, e.g., syringes, or another medical therapy with a similar therapeutic use.
For substitute products with the same API, pharmacists are often able to offer patients an option to substitute medical therapies. For example, many state laws require pharmacists to substitute generic pharmaceuticals, when a generic pharmaceutical is available for a branded product, i.e., a medical therapy with a proprietary name. In other instances, pharmacists may offer a patient the option for a generic pharmaceutical, because it would save the patient money, based on the patient's medical insurance coverage. In yet other instances, a patient may be required for medical insurance coverage to substitute for the prescribed branded drug medical therapy with a similar therapeutic use but a different API, often because the substitute API has an available generic pharmaceutical. For example, an insurance company could require a patient to use a generic form of birth control pharmaceutical over a new, branded birth control pharmaceutical product.
In some cases, the physician may choose to prevent generic or other substitution by specifically requiring that the prescription may be dispensed or delivered only with the branded product. In other instances, direct substitution may not be possible, because there is no substitute product, or the product is provided with restricted access. In the latter case, a generic product may be available, but it may be available only under a different restricted access program.
FDA required, for example, the manufacturers of the initial generic products for Accutane® (generic: isotretinoin), to provide risk management programs that contained the “same essential elements” of the risk management program developed for the branded product. Because isotretinoin is a potent teratogen with potential to cause severe birth defects, both the branded and generic risk management programs were designed to help prevent fetal exposure to isotretinoin. The initial risk management programs for the generic isotretinoin were separately maintained and managed, but the prescriptions were delivered similarly at the pharmacy.
Conventional approaches for delivering a substitute medical therapy, such as a generic pharmaceutical, with restricted access or distribution have not always been successful. In some situations, moreover, the substitute medical therapy may even provide an alternative restricted access or distribution that achieves the same goals. For example, there is no generic substitute for the branded pharmaceutical Thalomid® (generic: thalidomide). The restricted access program for Thalomid® requires dispensing pharmacies to be “registered” and prescriptions to be “validated” in a computer readable medium that can only be accessed by “registered” pharmacies. Pharmacies that choose not to be “registered”, for example, may not dispense Thalomid®, because they do not have access to the computer-generated validation code. As a result, generic manufacturers must develop alternative methods to deliver thalidomide to potential patients through an alternative distribution channel.
One example of a proposed invention for providing substitution of equivalent medical therapies related to U.S. Patent Application No. 2005/0065645, submitted by Liff, et al., entitled, “Method for Controlling a Drug Dispensing System.” This relates to an automated pharmaceutical dispensing system to receive and dispense a prescription via an adapted cabinet, which involves providing the operator an opportunity to select a generic substitution product. The system updates label data to include the generic drug information, maintains an inventory and keeps track of the drugs that have been dispensed.
Another example where pharmaceuticals may be substituted concerns U.S. Pat. No. 6,260,761, issued, to Peoples, entitled, “System and Method for Accurately Dispensing Prescriptions in a Pharmacy.” This relates to a device and method for converting product-specific identification numbers associated with bar code indicia on pharmaceutical products to an industry standard identification number. The process involves reading a bar code indicia, converting the indicia into an input string and standardizing the input string by means of adding or subtracting characters in accordance with rules based on the bar code length and input string. Pharmaceutical products of two different sources may be compared to determine if they contain the same drug as determined by the standard identification number. After receiving prescription information (bar code) that identifies a requested medical item, a substitution list is created that identifies at least one requested medical item and an equivalent item, and outputs the dispensing information for the selected medical item on the substitution list in response to substitution rules in a database.
Another example where pharmaceuticals may be substituted relates to U.S. Patent Application No. 2004/0215369, submitted by Rosenblum entitled, “Automatic Prescription Drug Dispenser.” This relates to an automatic prescription drug dispenser, including a remote dispenser, a prescription entry system, and a communications network. The remote dispenser transmits and receives information from the communications network and dispenses prescription drugs to the patient. The prescription entry system transmits and receives information from the communications network and provides an input system for the prescriber to electronically enter individual prescriptions for each patient. The communications network coordinates communications between the prescriber, insurance carrier, and the remote dispenser. As part of the prescription writing process, the patient's insurance plan can be uploaded to the computer along with other patient information. Each drug viewed by the prescriber will usually indicate whether it is on the patient's insurer's formulary along with its approval status and whether the drug is in the remote dispenser. If the drug is not on the insurer's formulary, the prescriber may be prompted to a drug of the same therapeutic class that is covered on the patient's insurer's formulary. If the drug is not in the remote dispenser, the prescriber may determine from the patient whether the patient desires any of the products available from any of the remote dispensers, or, if not available, a printed traditional prescription that may be taken to a pharmacy of the patient's choice for dispensing.
Yet another example where pharmaceuticals may be substituted concerns U.S. Patent Application No. 2004/0153336, submitted by Virdee, et al entitled, “Prescription. Creation and Adjudication Method.” This relates to a computer-implemented method for creating a prescription for treatment of an injury or illness covered by a workers' compensation system, which facilitates on-line adjudication of workers' compensation claim. The patient name, employer name and type and quantity of medication prescribed are input. During prescription writing, a formulary text box can be used to provide an indication whether the prescribed medication is included in the patient's formulary by comparing the prescribed medication to a list of medications contained in a formulary database. The user can obtain further information on the drugs in the drug database or can identify alternative medications by selecting an alternative medication link. The selected drugs will appear in a currently selected medications list, where a prescription provider may then be selected to route the claim for on-line adjudication and to fill the prescription.